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Study of JMKX003948 Ophthalmic Suspension in Healthy Participants

StatusNot Yet Recruiting
PhasePhase 1
SponsorJemincare
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 18, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
Jemincare
23 trials monitored
See all monitored trials
The study is a randomized, double-blind, placebo-controlled, phase 1 study of JMKX003948 Ophthalmic Suspension to evaluate the safety, tolerability and PK of single and multiple ascending doses in healthy participants. Participant will be randomized to receive either JMKX003948 Ophthalmic Suspension (1%, 2%, 3% or 5%) or matching placebo (JMKX003948 Ophthalmic Suspension: placebo= 6: 2, N=8 per cohort). Five cohorts (Cohort 1-5) are planned. Cohorts could also de-escalate to a lower concentration if current formulation was not tolerated (Cohort 1b, 2b and 3b). In case of de-escalation, Cohort 1b and 2b will continue to escalate to Cohort 1c and Cohort 2c, respectively. Participants will be admitted to the site on Day -1 after screening (up to 28 days), and remain domiciled until Day 14 for Cohort 1-4, Day 8 for other cohorts.
Trial Details
NCT Number NCT06832657
Lead Sponsor Jemincare
Conditions
(from sponsor)		 Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME)
Related terms Macular Degeneration
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov